> Creating Tomorrow’s Packaging Today:
Technology and Collaboration-Based Approaches to Optimize Pharmaceutical Package Design

Creating Tomorrow’s Packaging Today: Technology and Collaboration-Based Approaches to Optimize Pharmaceutical Package Design Session Description: This session will examine existing and emerging challenges in pharmaceutical package design including product stability, branding, cost, regulatory and patient compliance. Examples of new approaches backed by science-based predictive technologies to overcome these challenges much more rapidly and inexpensively than […]

ASAP Fundamentals – Garry Scrivens

ASAP Fundamentals – Garry Scrivens Accelerated Stability Assessment Protocols (ASAPs) are gaining increasing acceptance across the pharmaceutical industry as a means of predicting shelf life and understanding the effects of temperature and humidity on pharmaceutical stability. In this presentation the theory and fundamentals of ASAPs are reviewed and discussed, covering topics such as the shapes […]

Application of ASAP in early API and formulation development

Application of ASAP in early API and formulation development This presentation discusses the scientific and risk basis of using alternative stability assessment approaches in early API and formulation development. During early clinical development, turnaround time is crucial to support a fast paced project timeline. Alternative approaches such as ASAP fits into the early development environment nicely […]

Full System Moisture Management for Drug Preservation

Full System Moisture Management for Drug Preservation Moisture is a primary factor that can affect the stability of pharmaceuticals.  Exposed to excessive humidity, capsules can swell and aggregate, powdered ingredients can clump and moisture might directly affect the chemical stability of the drugs. All of these changes of physical or chemical properties can cause a […]

Abstract: Applications of Accelerated Stability Assessment Program (ASAP) in Pharmaceutical Development

Applications of Accelerated Stability Assessment Program (ASAP) in Pharmaceutical Development The presentation describes examples in utilizing the Accelerated Stability Assessment Program (ASAP) to support various areas of application within a commercial space. Using the Arrhenius principle in combination with moisture transfer modeling and statistical data analysis, the program has provided support for formulation screening to […]

Abstract: Film Coating for Protection during In-Use Applications

Film Coating for Protection during In-Use Applications Film coating provides a number of advantages from product protection and packaging efficiencies, through improved swallowability, better differentiation and patient compliance.  Barrier coatings provide the final layer of moisture protection after the product is removed from the primary packaging.  Recent advances in moisture barrier coating systems are presented. […]

SOS-2015 Case Studies: Stress Testing Revealing Degradation Pathways:

Stress Testing Revealing Degradation Pathways: Despite a thorough stability assessment, unexpected degradation processes can occur throughout every phase of drug development or even after market launch. Since drug decomposition may have a myriad of manifold root causes, a well designed forced degradation strategy can help to reveal potential stability issues long before requiring exceptional financial […]

Abstract: Modeling of Degradation Chemistry at AstraZeneca

Modeling of Degradation Chemistry at AstraZeneca One key step in the drug product development process is to select which aggregation state the active pharmaceutical ingredient (API) should have to obtain optimal product and process performance. The objective at the form selection step is to choose the preferred aggregation state of the API with respect to […]

Abstract: Excipient Compatibility as Predicted by ASAP: A Case Study

Excipient Compatibility as Predicted by ASAP: A Case Study With the advent of the Accelerated Stability Assessment Program (ASAP), a novel approach to excipient compatibility testing is now possible. Formulation development begins with the process of selecting excipients that do not adversely affect the chemical stability of the drug substance. Traditionally, excipient compatibility studies have […]